Dual dispensing tablet container

ABSTRACT

A container for dispensing pharmaceutical and non-pharmaceutical tablets is described. The container comprises a prescription tablet pouch, a non-prescription pouch and a header label indicating the time at which the contents of the pouches are to be consumed. The prescription tablet pouch is configured to receive at least one type of prescription drug tablet. The non-prescription tablet pouch is separably coupled to the prescription tablet pouch and is configured to receive at least one type of non-prescription tablet. The header label is separably coupled to the prescription tablet pouch.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

The present patent application claims the priority of provisional patent application No. 61/245,899, filed Sep. 25, 2009. The present patent application is also a continuation-in-part of patent application Ser. No. ______

FIELD OF THE INVENTION

The present invention relates to a container comprising a pouch for prescription tablets, a pouch for non-prescription tablets, and a header label indicating a time at which the contents of the pouches are to be consumed.

BACKGROUND

One of the major problems in taking prescribed daily medications emanates from patients having to take more than one medication in the form of pills or tablets. A principal concern is determining whether all medications are in compliance with the prescribed daily regimen. Many times this concern is compounded by the requirement that portions of the different medications must be taken at different times of the day.

One solution to the problem of taking multiple medications is to pre-package the multiple medications so that users can take the pre-packaged medications at a predetermined time. Generally, methods of pre-packaging medications are targeted to patients that may lack maturity or mental capacity to take the correct medications at the correct time. Some of the pre-packaged medications are placed in a small plastic bag, which may be easily misplaced. Other pre-packaged medications are placed in sealed cups that are difficult to open.

An added complication of multiple medication regimens is that often a particular patient may be advised to take one or more non-prescription medications, such as nutraceuticals, vitamins and/or other beneficial supplements in addition to his prescription medications. It would be beneficial to include any non-prescription pills to be consumed by that patient in compliance packaging to ensure that the patient is able to easily comply with his entire regimen, prescription and non-prescription alike. Further, it is even simpler and easier for the patient if both prescription and non-prescription regimens are integrated into one complete compliance package.

Yet another complication of multiple medication regimens is that many patients may require variable doses of a given medication at different times. For example, many medications require titration when a patient begins taking them. This generally involves the patient taking gradually larger amounts of the drug until the desired dosage amount is reached. Still other regimens require that a given tablet be taken every other day, or that different dosages be taken on alternating days. These schedules make it even more difficult for a patient to comply with the medication regimen that has been prescribed or recommended.

Although multiple prescription filling systems are available, e.g. the McKesson PACMED system, these systems have limited capabilities. For example, these filling systems fail to assemble a multiple prescription order that can be easily transported and administered. Additionally, these filling systems fail to effectively organize the multiple prescription medications. Furthermore, the filling systems fail to organize the multiple prescription containers. Further still, the filling systems fail to provide a compliance packaging solution.

It would thus be desirable to have compliance packaging having a label associated with prescription and non-prescription tablets to be taken by a patient at a particular time, the label indicating the time at which the tablets are to be consumed.

SUMMARY

A container for dispensing pharmaceutical and non-pharmaceutical tablets is described. The container comprises a prescription tablet pouch configured to receive at least one type of prescription drug tablet. The container further comprises a non-prescription tablet pouch configured to receive at least one type of non-prescription tablet. The non-prescription pouch is separably coupled to the prescription tablet pouch. The container also comprises a header label comprising information indicating a time at which the contents of both the prescription tablet pouch and the non-prescription tablet pouch are to be consumed. The header label is separably coupled to the prescription tablet pouch.

In another embodiment, a strip of containers for dispensing pharmaceutical and non-pharmaceutical tablets is described. The strip of containers comprises at least one container separably coupled to another container. Each container comprises a prescription tablet pouch configured to receive at least one type of prescription drug tablet. Each container further comprises a non-prescription tablet pouch configured to receive at least one type of non-prescription tablet. The non-prescription pouch is separably coupled to the prescription tablet pouch. Each container also comprises a header label comprising information indicating a time at which the contents of both the prescription tablet pouch and the non-prescription tablet pouch are to be consumed. The header label is separably coupled to the prescription tablet pouch.

In yet another embodiment, a method for packaging pharmaceutical and non-pharmaceutical tablets is described. The method comprises receiving at a server an order for tablets. The order comprises an order for at least one type of prescription tablet and an order for at least one type of non-prescription tablet. The server generates instructions for filling a plurality of pouches for prescription tablets and pouches for non-prescription tablets. The pouches for prescription tablets and pouches for non-prescription tablets are filled by automated means. A plurality of labels are printed by automated means. The labels comprise information indicating the time at which the contents of the prescription tablet pouch and non-prescription tablet pouch associated with each label are to be consumed.

DRAWINGS

The present invention will be more fully understood by reference to the following drawings which are for illustrative, not limiting, purposes.

FIG. 1A shows a pair of prior art heated rollers that cut and seal the illustrative pouches.

FIG. 1B shows a side view of a prior art cutting block and a prior art cutting blade shown in FIG. 1A.

FIG. 1C shows a side view of the prior art cutting block and the prior art cutting blade that are both fixedly coupled to the heated rollers of FIG. 1A.

FIG. 1D shows a sealed prior art pouch with a single side cut adjacent to the prior art cutting blade.

FIG. 2A shows an isometric view of a center cut cutting blade that is used to generate a separable pouch with a center cut.

FIG. 2B shows an inverted side view of the center cut blade shown in FIG. 2A.

FIG. 2C shows an illustrative elevational side view of a cutting block and the center cut cutting blade.

FIG. 2D shows an exploded view of the cutting block and the center cut cutting blade.

FIG. 2E shows an illustrative strip that includes a sealed center cut pouch.

FIG. 3A shows an illustrative sealed center cut pouch with three perforations and four tearable ribbons on each side of the center cut.

FIG. 3B shows an illustrative sealed center cut pouch with four perforations on each side of the center cut.

FIG. 3C shows an illustrative sealed center cut pouch with five perforations on each side of the center cut.

FIG. 4 shows an illustrative arrangement of pouches associated with an individual regimen.

FIG. 5 shows a portion of an illustrative strip of pouches.

FIGS. 6 a-6 d show an illustrative strip of stackable individual sealed medicament containing cups.

FIGS. 7 a-7 d show the manner in which an illustrative strip may be folded from its flat configuration to its stacked configuration.

FIGS. 8A and 8B show a portion of one illustrative embodiment of a strip of pouches associated with an individual regimen, including illustrative labeling information.

FIGS. 9A and 9B show one embodiment of the stackable individual medicament cups, including illustrative text associated with an individual regimen.

FIGS. 10A and 10B show one embodiment of the stackable individual medicament cups, including illustrative text associated with an individual regimen.

FIG. 11A shows a group of seven separable pouches, wherein each pouch comprises a plurality of different tablets.

FIG. 11B shows an exploded view of the illustrative front side of one of the sealed center cut pouches associated with an individual regimen and containing prescription medication that is included in the strip of pouches.

FIG. 11C shows an exploded view of the illustrative back side of the pouch in FIG. 11B.

FIG. 12A shows a group of seven separable pouches, wherein each pouch comprises a plurality of different tablets.

FIG. 12B shows an exploded view of the illustrative front side of one of the sealed center cut pouches associated with an individual regimen and containing nutraceuticals that is included in the strip of pouches.

FIG. 12C shows an exploded view of the illustrative back side of the pouch in FIG. 12B.

FIG. 13A shows four illustrative separable pouches and their associated headers, wherein each pouch comprises a plurality of different tablets and each header comprises printed information about the associated tablets.

FIG. 13B shows an exploded view of the illustrative front side of one of the sealed center cut pouches associated with an individual regimen and containing nutraceuticals that is included in the strip of pouches.

FIG. 13C shows an exploded view of the illustrative back side of the pouch in FIG. 12B.

FIG. 14A shows one illustrative configuration of pouches where the header is located above two pouches that are scheduled for one time period for administration to one individual.

FIG. 14B shows one illustrative configuration of pouches where the header is located between two pouches that are scheduled for one time period for administration to one individual.

FIG. 14C shows one illustrative configuration of pouches where no header is included.

FIG. 14D shows another illustrative configuration of pouches where the header is located between two pouches that are scheduled for one time period for administration to one individual.

FIG. 15A shows a plan view of blank used to form a foldable box configured to receive a plurality of center cut pouches.

FIG. 15B shows an isometric view of an assembled box without any print placed on the blank.

FIG. 16A shows a label area on a pre-assembled blank that is similar to the blank described in FIG. 15A.

FIG. 16B shows a variety of printable areas on the back face of the assembled box.

FIG. 17 shows a folded box with an exposed label area or print area defined by the top wall and top side flaps.

FIGS. 18A-18G show an illustrative label on the folded box.

FIG. 19 shows an illustrative grouping for a 30-day tablet regimen for the patient management system.

FIG. 20 shows a secondary container that receives four primary containers or assembled boxes.

FIG. 21 shows a plurality of different secondary containers corresponding to four different dosage periods.

FIG. 22 shows another illustrative secondary container, with stackable medicament cups associated with an individual regimen contained within.

FIG. 23 shows another embodiment of a secondary container that receives four primary containers or assembled boxes.

FIGS. 24A and 24B show illustrative flowcharts of methods for compliance packaging for the patient medication management system.

FIGS. 25A-25C show an isometric view of the dual tablet dispensing container.

FIGS. 26A-26E show a flat plan view of an illustrative label.

FIG. 27 shows a first side view of the front side wall for the unopened dual tablet dispensing container.

FIG. 28 shows a second side view of the back side wall of the 30-day tablet dispensing container.

FIGS. 29A-29B show a third side view of the illustrative right-side wall of the 30-day tablet dispensing container.

FIG. 30 shows a fourth side view of the illustrative left-side wall of the 30-day tablet dispensing container.

FIG. 31 shows a top view of the top wall of the unopened 30-day tablet dispensing container.

FIG. 32 shows a bottom view of the 30-day tablet dispensing container.

FIG. 33 shows an illustrative front view of the opened 30-day tablet dispensing container that reveals illustrative pouches.

FIG. 34 shows an illustrative flowchart describing a method for packaging pharmaceutical and non-pharmaceutical tablets.

DESCRIPTION

Persons of ordinary skill in the art will realize that the following description is illustrative and not in any way limiting. Other embodiments of the claimed subject matter will readily suggest themselves to such skilled persons having the benefit of this disclosure. It shall be appreciated by those of ordinary skill in the art that the apparatus and systems described herein may vary as to configuration and as to details. Additionally, the methods may vary as to details, order of the actions or other variations without departing from the illustrative method disclosed herein.

The systems, apparatus and methods described herein provide the correct medications and dosages at the right time. The packaging is designed with clear images and names to simplify the process of determining the appropriate medications to take at the appropriate time. Additionally, the patient medication management system and method described herein eliminates the worry of taking the wrong medication at the wrong time and eliminates the need to manually open and organize prescriptions each week. Furthermore, the system and method described herein gathers all the patient's medicines together in one package, and clearly shows the proper dosage time.

The system and method described herein allows a patient or physician to seamlessly integrate OTC medications, vitamins, nutraceuticals and other beneficial supplements into a daily regimen. This can be particularly important in elderly patients. As people age, they tend to take an ever-growing number of medications, any of which can interact with another medicament or other substance they may ingest. For example, a physician may want a patient to take a non-prescription pill daily or on another regular regimen. One such example is 81 mg aspirin, often recommended for patients to take daily to help prevent certain types of heart and/or cardiovascular disease. Using the system and method described herein, the patient can have all pills in hand that need to be taken at one time without having to remember to open additional pill bottles and add extra pills to the regimen dispensed from the Dual Dispensing Tablet Container.

The Dual Dispensing Tablet Container can also be used to help avoid or diminish unwanted side effects of medications or food-medication interactions. For example, some breakfast foods are well-known to interact with some medications. Grapefruit and/or grapefruit juice can slow elimination of certain types of drugs (such as benzodiazepines, like valium) from the body, while oatmeal can decrease absorption of digoxin to almost nothing. Since some medications including benzodiazepines are already eliminated more slowly by elderly patients, taking grapefruit juice or eating grapefruit while a large dose of medication is still in an elderly patient's system could be particularly dangerous. Ingestion of a large quantity of oatmeal before taking a dose of digoxin may be equally dangerous, because the patient believes he has received the beneficial effect of the drug since he has consumed the medication, when in reality, the drug was not absorbed by the body due to the effect of the oatmeal. The Dual Dispensing Tablet Container helps prevent either type of interaction by simply scheduling such drugs for a time other than “morning” or “breakfast time”.

Other timing-related complications that interfere with patient compliance with prescribed or recommended medication regimens include when the dosage of a given drug is not regular or when the frequency with which a drug should be taken is not regular. Certain tablets must be taken only every other day to maximize their benefit to the patient. It can be very difficult for patients to comply with such complicated regimens. The Dual Dispensing Tablet Container can aid those patients by providing the proper dose at the proper time. The patient is not required to tell the difference between two dosages of the same tablet, nor is he required to calculate the proper interval between dosages. All calculations and identification are done ahead of time, before the patient ever sees the prescription container.

Another advantage of the Dual Dispensing Tablet Container is that it allows physicians or other health care providers to more closely monitor the non-prescribed pills that a patient may take each day, including vitamins, nutraceuticals, over-the-counter drugs or other pills. This can help prevent interactions between prescription medications and other pills. For example, aspirin can interact with blood thinners like Coumadin and/or antidepressants like Prozac to cause bleeding.

The terms “tablets”, “medications” and “medicaments” as used herein to refer to medications, pharmaceuticals, nutriceuticals, vitamins, capsules, gel caps, pills and other such medicinal or nutritional preparations for oral use as would be appreciated by those of ordinary skill in the art of pharmacy. The terms “prescription tablets”, “prescription medications” and “prescription medicaments” refer to pills and other such medicinal or nutritional preparations for oral use that are prescribed to a patient by a physician or other health care provider, as would be appreciated by those of ordinary skill in the art of pharmacy. The term “non-prescription tablets” refers to pills and other such preparations for oral use that may be obtained without a prescription.

The systems, apparatus and methods described herein provide assurances of the proper dosages at the proper period. Additionally, caregivers and patients get the assurance that the patient is getting the right medications and staying compliant with those medications. Furthermore, a time saving solution for dispensing tablets, medications and vitamins is described.

One of the patient medication management systems provides a compliant packaging solution. For purposes of this patent, the term “compliant packaging” refers to packaging tablets so that they are administered in a manner that complies with one or more prescriptions. Additionally, compliant packaging may also refer to providing reminders for taking medications and/or recording that the medications have been consumed.

By way of example and not of limitation, compliance packaging may include three elements: firstly, an action is initiated by a patient and/or caregiver with the compliance package; secondly, the compliance package dispenses at least one tablet as a result of the action taken by the patient and/or caregiver; and thirdly, the compliance package records the dispensing of the tablet. An illustrative example of a “compliance package” is the well-known birth control “dial pack” package, in which there are thirty tablets in a blister package that are in a circular configuration (not shown). To consume the tablet, the patient pushes on the transparent plastic material and the tablet pierces a foil backing. After the tablet is dispensed from the dial package, a record is left on the dial pack package, i.e. a pressed plastic housing and pierced foil backing.

Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors. The compliant package is consumed at a predetermined interval consistent with the prescription. Some compliant packaging solutions may record that each of the tablets is consumed.

One of the illustrative patient medication systems described herein satisfies the requirements for a compliance package because an action is required by the patient or caregiver that requires identifying the appropriate dosage period, e.g. morning, and selecting the appropriate pouch or pouches. The patient or caregiver records the consumption of the medication by removing the packet containing the appropriate medication from the container and consuming the medication. Since the packet is imprinted with a dosage time period and date for consumption, a patient or caregiver can tell at a glance whether the medication for the current date and dosage period has already been consumed or whether it remains to be taken.

Referring to FIG. 1A there is shown a pair of prior art heated rollers that cut and seal the illustrative pouches that hold the tablets. The illustrative pouch 12 is cut and perforated by a cutting blade 14 and cutting block 16 that is fixedly coupled to heated roller 18 and heated roller 20, respectively. The heated rollers also seal the end 19 of the pouch 12. The heated roller 18 includes a second cutting blade 22 that cuts, perforates and seals the opposite end of the pouch 12 (not shown). The second heated roller 20 includes a second cutting block 24 that is located at an equidistant point from the cutting block 16. The illustrative rollers 18 and 20 also seal the edges of the pouch. The illustrative combination of the heated rollers 18 and 20 and cutting blade 14 and cutting block 16 may be found in a PACMED™ system sold by the McKesson Corporation from Pennsylvania.

Referring now to FIG. 1B there is shown a side view of the cutting block 16 and cutting blade 14 that are both fixedly coupled to the heated rollers of FIG. 1A. The cutting blade 14 has a flat face 26 and a pointed edge 28.

In FIG. 1C there is shown a side view of the cutting block 16 and cutting blade 14 that are both fixedly coupled to the heated rollers of FIG. 1A. Generally, block 16 is a rectangular block shaped metal alloy. The cutting blade 14 may be composed of the same or similar metal alloy and includes a single side cut 30 of a predetermined length and a plurality of smaller cuts such as 32 a that score or cut the pouch 12 and provide perforations between the heat-sealed edges of each pouch.

In FIG. 1D there is shown an illustrative sealed prior art pouch with a single side cut adjacent to the prior art cutting blade 14. The illustrative pouch 34 includes a single cut 36, a plurality of perforations such as perforation 38 a, a sealed top edge 40, a sealed bottom edge 42, and a sealed side edge 44. In the illustrative embodiment, the pouch 34 is formed by taking a plastic sheet composed of a polymeric compound and folding the plastic sheet over and sealing the side edge 44 and the sealed bottom edge 42 and sealed top edge 40. The length of the single cut 36 is determined by the single side cut 30.

The plastic pouch materials may be obtained with the PACMED™ system and the consumables are sold by the McKesson Corporation; however, the chemical and material properties of the plastic materials have not been publicly disclosed. Regardless, the inventors have discovered that there are various limitations corresponding to the plastic pouch materials. In the embodiments disclosed herein, the plastic “pouch” material is sold as a consumable for the PACMED system. Alternatively, an AUTOMED packaging system may also be used.

In general, the plastic pouches generated by the PACMED machines do not tear easily. The single cut 36 and multiple perforations 38 a result in the tearing of the existing pouch and adjacent pouches. Although, each the perforations 38 a are intended to facilitate horizontal tearing, the perforations 38 a regularly result in a tear taking a circuitous route that tears the existing pouch or adjacent pouch. Thus, when a user tears the prior art pouches, there is a likelihood that the resulting tear is not horizontal and tears the sealed pouch holding the tablets or the adjacent sealed pouch.

Additionally, it appears that there is a film grain 46 corresponding to the plastic materials that result in vertical tearing of the pouches, so that upon attempting to separate a first pouch from a second pouch, a tear occurs with significant frequency on either pouch itself or the adjacent pouch that would result in tablets being spilt on a table or floor. The complexity of this problem is magnified by the plastic pouch materials being sold exclusively by McKesson Corporation and there being no alternative pouch materials that operate with the PACMED system.

Referring to FIG. 2A there is shown an isometric view of a center cut blade that is used to generate a separable pouch with a center cut. The center cut blade 50 generates separable pouches that enable a patient or caregiver to access the medications in the pouches without tearing adjacent pouches. The center cut blade 50 is fixedly coupled to heated rollers 18 shown in FIG. 1A. The heated rollers 18 and 20 are configured to seal each pouch and to also cut the plastic pouch material. The illustrative cutting blade 50 has a top edge 52 and a bottom face 54.

Referring to FIG. 2B there is shown an inverted side view of the center cut blade shown in FIG. 2A. The top edge 52 of the center cut blade 50 comprises a first side cut 56 having a c₁ length, a center cut 58 having a c₂ length, and a second side cut 60 having a c₃ length. The first side cut 56 and second side cut 60 are on each end of the blade 50. The center cut 58 is in the middle of the blade 50 and is separated from the first side cut 56 by perforation cuts 62 a, 62 b and 62 c. On the opposite end, the second side cut 60 is separated from the center cut 58 by the perforation cuts 64 a, 64 b, and 64 c. Each perforation is a relatively small cut compared to either the side cuts or the center cut. The center cut length is greater than the length of each side cut.

For example, in a broad illustrative embodiment the dimensions of the first side cut 56 c₁ length can range from 1.0 mm to 20.0 mm. The dimensions of the second side cut 60 c₃ length can range from 1.0 mm to 20.0 mm. The center cut 58 c₂ length can range from 1.0 mm to 50.0 mm. The number and size of perforation cuts can also vary. For example, there may be 1 to 10 perforation cuts in the broad illustrative embodiment, and the width of the perforation cuts can vary from 0.1 mm to 2.0 mm.

In a more limiting embodiment, the dimensions of the first side cut 56 c₁ length can range from 5.0 mm to 15.0 mm. The dimensions of the second side cut 60 c₃ length can range from 5.0 mm to 15.0 mm. The center cut 58 c₂ length can range from 20.0 mm to 40.0 mm. The number and size of perforation cuts can also vary. For example, there may be 2 to 5 perforation cuts in the less broad illustrative embodiment, and the width of the perforation cuts can vary from 0.5 mm to 1.5 mm.

In the preferred embodiment shown in FIG. 2B, the length of first side cut 56 is approximately 10 mm, and for second side cut 60, is approximately 10 mm. The center cut 58 is approximately 35 mm. In the preferred embodiment, there are three perforation cuts resulting in four tearable ribbons on each side of the center cut 58. The width of the perforation cuts is approximately 1.0 mm, and each of the tearable ribbons is approximately 1.0 mm.

Referring to FIG. 2C, there is shown an illustrative elevational side view of a cutting block 66 and the center cut blade 50. This profile of the center cut blade 50 and the cutting block 66 shows that the center cut blade 50 has the same profile as the prior art cutting blade 14 shown in FIG. 1B. In operation, the center cut blade 50 and cutting block 66 are fixedly coupled to rotating heated rollers that effectively cut and seal the pouch. The illustrative heated roller described herein provides a dual role, namely, the heated roller provides a means for forming sealed pouches because the heated roller is used to seal the plastic pouch material. Additionally, once the center cut blade is placed in the heated roller, the combination provides a means for separating each sealed pouch without tearing the existing sealed pouch or tearing the adjacent sealed pouch.

Referring to FIG. 2D, there is shown an exploded view of the cutting block and the center cut cutting blade. A more detailed view of the center cut blade 50 depicts the first side cut 56 adjacent to a first u-shaped well 68 a that is adjacent the perforation cut 62 a. Note, the terms “u-shaped well” and “well” are used interchangeably. A second u-shaped well 68 b follows and is adjacent to another perforation cut 62 b that is also adjacent well 68 c. Well 68 c is also adjacent to perforation cut 62 c which is, in turn, adjacent to well 68 d. Adjacent to well 68 d is the center cut 58. The center cut 58 is separated from the second side cut 60 by the alternating combinations of the perforation cuts 64 a-64 c and wells 70 a-70 d. The first side cut 56 and second side cut 60 are on each end of the blade 50. The illustrative four wells 68 a-68 d and 70 a-70 d generate four ribbons on the plastic pouches that are between each side cut and the center cut that are described in further detail below.

Referring back to FIG. 2A the u-shaped wells 68 a-68 d and 70 a-70 d are not sharpened and do not cut the plastic pouch materials. As a result, “ribbons” are produced that connect or couple the pouches to one another.

The separable sealed pouches may then be grouped into collections of seven pouches (for the seven-day box), twenty-eight pouches, thirty pouches or any other such combination. A plurality of sealed pouches that are grouped is also referred to as a “strip,” and the terms “strip” and “group of pouches” is used interchangeably in this patent. A typical strip includes seven pouches, twenty-eight pouches, or thirty pouches. In one embodiment described in further detail below, a reminder strip consists of seven pouches, followed by an empty pouch with printing on the pouch to remind the patient and/or caregiver to re-order, and two remaining pouches. In another embodiment, there are twenty-eight pouches followed by an empty pouch with printing on the pouch to remind the patient and/or caregiver to re-order and two remaining pouches

Referring now to FIG. 2E there is shown an illustrative strip 71 that includes a sealed center cut pouch 72. The illustrative pouch 72 is adjacent to pouch 74 and pouch 76. By way of example and not of limitation, the illustrative pouch 72 comprises a sealed top end 78, a sealed bottom end 80, and two sides, in which at least one side is also sealed, e.g. side seal 82, and the other side is folded over. Each illustrative pouch includes different tablets corresponding to different medications, vitamins or other such medicinal or nutritional preparation for oral use.

Additionally, the illustrative pouch is joined to an adjacent pouch by a plurality of tearable ribbons 84 a-84 d adjacent to the first side cut 85 a adjacent the top end 78. A similar grouping of tearable ribbons is also adjacent to the second side cut 85 b adjacent to the top end. Each sealed pouch comprises side cuts 85 a and 85 b on each side of the top end 78 and side cuts 85 c and 85 d on each side of bottom end 80.

The illustrative embodiment shows a pouch with at least three perforations between each side cut and the center cut. The first ribbon 84 a is disposed between the first side cut 85 and the first perforation 86 a. The second ribbon 84 b and third ribbon 84 c are each disposed between perforations 86 a, 86 b and perforations 86 b, 86 c, respectively. The fourth ribbon 84 d is disposed between the third perforation 86 c and the center cut 87 a. A similar configuration of perforations and ribbons surround the center cut 87 b that is adjacent to the bottom end 80. In the illustrative example, the ribbons have a width corresponding to the width of the u-shaped well.

The resulting pouch can be opened on either side and the center cut prevents tearing the existing pouch or the adjacent pouch. In general, the pouch described minimizes the number of tearable ribbons, thereby minimizing the likelihood of tearing the existing pouch or the adjacent pouch. Additionally, having the tearable ribbons at the edges of the pouch also minimizes the likelihood of tearing into the existing or adjacent pouches.

It shall be appreciated by those of ordinary skill in the art having the benefit of this disclosure that the resulting pouch will vary depending on the type of pouch material being used, the thickness or weight of the pouch material, the seal, the length of the cuts, the number of cuts, the length of the perforations, number of perforations, the width of the tearable ribbons and the frequency of tearable ribbons. For example, in FIG. 3A there is shown the illustrative sealed center cut pouch 72 described above with three perforations and four tearable ribbons on each side of the center cut. In FIG. 3B there is shown an illustrative sealed center cut pouch 88 with four perforations on each side of the center cut. FIG. 3C depicts another illustrative sealed center cut pouch 89 with five perforations on each side of the center cut.

Referring to FIG. 4 there is shown an illustrative layout of pouches associated with all pills to be consumed by one individual at a particular date and time and associated with an illustrative individual regimen. Header 802 does not contain any tablets. Instead, illustrative information is provided. Pouch 804 represents a pouch containing tablets associated with one or more prescriptions associated with an illustrative individual regimen. Pouch 806 represents a pouch containing non-prescription tablets associated with an illustrative individual regimen.

Referring to FIG. 5 there is shown a portion of the layout of a strip of pouches associated with an illustrative individual regimen, showing that the header 802 a and the associated pouches 804 a and 806 a to be administered at one date and time are continuous with the header 802 b and pouches 804 b and 806 b for the subsequent date and time. As shown, a dosage unit comprising a header and at least one pouch may be continuous with one or more dosage units.

Referring to FIGS. 6 a-6 d there is shown a portion of the layout of a strip of sealed medicament cups that are associated with an illustrative individual regimen. FIGS. 6 a-6 d show the same strip portion in a variety of configurations.

FIGS. 7 a-7 d illustrate the manner in which a flat strip of medicament cups associated with an individual regimen may be folded into a stackable configuration for use with a secondary container.

FIGS. 8A and 8B show a portion of one illustrative embodiment of a strip of pouches, including illustrative labeling information associated with an individual regimen. As shown, in this embodiment, the header is associated with the two pouches that immediately follow it on the strip of pouches.

FIGS. 9A and 9B show an illustrative container and illustrative labeling for one embodiment of a strip of medicament cups. FIG. 9A shows one illustrative layout of the strip of medicament containers, in which the header (material between cups) is configured to be printed with illustrative information about the individual integrated order and the associated patient and pill regimen. In this embodiment, the lids of the cups are marked with illustrative symbols to clearly indicate which cups hold the prescription medicaments and which cups hold the non-prescription tablets, such as nutraceuticals, vitamins and other beneficial supplements. Further, the header area is configured to be coupled to one of two adjacent cups that correspond to a single date and time for a particular individual to consume the tablets within and the header portion has information related to the contents of both adjacent cups. FIG. 9B shows illustrative labeling including the name of the patient, the date the tablets should be consumed, the time of day the tablets should be taken, the name of the prescribed medication, the name of the corresponding generic, the dosage and the prescription number. Additionally, an expiration date is included that identifies the medications that should not be taken after the expiration date.

FIGS. 10A and 10B show illustrative container and illustrative labeling for another embodiment of a strip of medicament cups. FIG. 10A shows one illustrative layout of the strip of medicament containers, in which the header 1001 (material between cups) is configured to be printed with illustrative information about the individual integrated order and the associated patient and pill regimen. In this embodiment, the lids of the cups are marked with illustrative inverted colors to clearly indicate which cups hold the prescription medicaments and which cups hold the non-prescription medicaments, such as nutraceuticals, vitamins and other beneficial supplements. Further, the header area is configured to be coupled to each of two adjacent cups that correspond to a single date and time for a particular individual to consume the tablets within; the header portion has an additional perforation that allows each header portion to be separated from rest of the strip along with the corresponding medicament cup. FIG. 10B shows an illustrative header labeling including the date the tablets should be consumed, the time of day the tablets should be taken, the name of the prescribed medication and the dosage.

Referring to FIG. 11A there is shown a group of fourteen separable pouches, wherein each pouch comprises a plurality of different tablets. The separable sealed pouches have been grouped into a collection of fourteen pouches 90 that correspond to a seven day supply of medications. A plurality of sealed pouches that is grouped is also referred to as a “strip,” and the terms “strip,” “group of pouches,” and “strip of pouches” is used herein interchangeably.

Referring to FIG. 11B there is shown an exploded view of the illustrative front side of one of the sealed center cut pouches 92 that contain prescription medication that is included in the strip of pouches 90. The exploded view shows that a variety of data fields are printed on the front of each pouch. In general, the data fields provide information corresponding to each tablet within the pouch. The data fields include: the name of the patient 94 a, the date the tablets should be consumed 94 b, the time of day the tablets should be taken 94 c, the name of the prescribed medication 94 d, the name of the corresponding generic 94 e, the dosage 94 f, and the prescription number 94 g. Additionally, an expiration date 94 h is included that identifies that the medications should not be taken after the expiration date.

Referring to FIG. 11C there is shown an exploded view of the illustrative back side of the pouch 92 in FIG. 4B. The data fields include: the name of patient 96 a, a bar code 96 b, the address of the facility that filled the pouches with tablets 96 c and the telephone number 96 d for additional information. The illustrative bar code associates the tablets in the foldable box with a particular patient.

Referring to FIG. 12A there is shown a group of fourteen separable pouches, wherein each pouch comprises a plurality of different tablets. The separable sealed pouches have been grouped into a collection of fourteen pouches 90 that correspond to a seven day supply of medications. A plurality of sealed pouches that is grouped is also referred to as a “strip,” and the terms “strip,” “group of pouches,” and “strip of pouches” are used herein interchangeably.

Referring to FIG. 12B there is shown an exploded view of the illustrative front side of one of the sealed center cut pouches 1292 that contains non-prescription medication, nutraceuticals, OTC medication and or other beneficial pills. The exploded view shows a variety of data fields that are printed on the front of each pouch. In general, the data fields provide information corresponding to each tablet within the pouch. The data fields may include: the name of the patient 98 a, the date the tablets should be consumed 98 b, the time of day the tablets should be taken 98 c, the name of the non-prescription medication or nutraceutical 98 d, the scientific name or alternate common name of the medication or nutraceutical 98 e, the dosage 98 f, and indications or possible uses for the nutraceuticals 98 g and 98 i. Additionally, an expiration date 98 h is included that indicates that the contents of the packet should not be taken after the expiration date.

Referring to FIG. 12C there is shown an exploded view of the illustrative back side of the pouch 1292 in FIG. 12B. The data fields include: the name of patient 97 a, a bar code 97 b, the address of the facility that filled the pouches with tablets 97 c, and the telephone number 97 d for additional information. The illustrative bar code associates the tablets in the foldable box with a particular patient.

Referring to FIG. 13A there is shown a group of separable pouches, wherein each pouch comprises a plurality of different tablets. The separable sealed pouches have been grouped into pairs of pouches 828 and 828 a that correspond to medications to be consumed at the same time by the same individual. Only two illustrative pouch groups are shown.

Referring to FIG. 13B there is shown an exploded view of the illustrative front side of one of the sealed center cut pouches 1392 that contains non-prescription medications and/or nutraceuticals.

Referring to FIG. 13C there is shown an exploded view of the illustrative back side of the pouch 1392 in FIG. 13B. The data fields include: the name of patient 97 a, a bar code 97 b, the address of the facility that filled the pouches with tablets 97 c, and the telephone number 97 d for additional information. The illustrative bar code associates the tablets in the foldable box with a particular patient.

Referring now to FIGS. 14A-D, portions of strips of pouches are shown to represent illustrative configurations of filled packets and associated headers. In FIG. 14A, the two packets that are to be consumed at the same time are located under a header that indicates the correct date and time period for administration. In FIG. 14B, the illustrative header that indicates the correct date and time period for administration is located between the two packets that are to be consumed at the same time. FIG. 14C shows an illustrative reverse side of a “headerless” embodiment. FIG. 14D shows the reverse side of an illustrative header where the header is the same size as the packets that hold medicaments and nutraceuticals. Illustrative text that may appear on the reverse side of the illustrative embodiments of FIGS. 14A and 14B as well as 14D is also included in FIG. 14D.

The illustrative seven-day strips of FIGS. 14A-14D are placed in an illustrative seven-day container or in an illustrative 30-day container before being delivered to the patient. Illustrative seven-day containers are presented in FIG. 15A through FIG. 17 and FIGS. 19-23. An illustrative 30-day container is presented in FIGS. 25A-25C and FIGS. 27-33.

Referring to FIG. 15A there is shown a plan view of a blank 110 used to form an assembled box 180 (shown in FIG. 15B) that holds a plurality of pouches, wherein each pouch includes a plurality of different tablets. The foldable box is formed from a single piece of cardboard configured to receive a plurality of pouches as described herein. The blank 110 is formed from a corresponding stamping die that presses against a large piece of cardboard and cuts out the perimeter of the blank and forms the scores, holes and other cuts on the blank, in a manner well known in the art of box making. The scores are depressions in the blank 110 and are formed by projections on the dies that press into the corrugated cardboard blank 110 sufficiently to form a score or fold line, but not cut all the way through the blank 110. The cuts or perforations in blank 110 are formed by sharpened depressions on the die that cut all the way through the blank.

By way of example and not of limitation, the illustrative cardboard or blank 110 includes an outer smooth layer of paper and a thick interior layer. The outer smooth layer may receive printed text or images using an illustrative laser printer, ink jet printer or other such printing means.

The blank 110 comprises a top wall 112 that provides a closure for the assembled box 180 that is shown in FIG. 15B. Adjacent to the top wall 112 are two top wall side flaps 116 a and 116 b that are separated by fold lines 114 a and 114 b, respectively. The combination of the top wall 112 and the top wall side flaps 116 a and 116 b provides a printable area that may be configured to receive toner or ink or even a label corresponding to a particular patient. Additional details about an illustrative label defined by the top wall 112 and top wall side flaps 116 a and 116 b is described below.

A back wall 118 is adjacent to the top wall 112. The back wall 118 is bounded by back wall fold lines 120 a and 120 b that are adjacent to back wall tabs 122 a and 122 b, respectively. The back wall 118 is separated from the top wall 112 by a top wall/back wall fold line 124.

A bottom wall 126 is adjacent the back wall 118. The bottom wall 126 is bounded by bottom wall fold lines 128 a and 128 b. The illustrative bottom fold line 128 a includes two cuts, namely, cuts 130 a and 130 a′. Additionally, the bottom fold line 128 b also includes two cuts, namely cut 130 b and 130 b′. The bottom wall 126 is separated from the back wall 118 by a back wall/bottom wall fold line 132.

A first side wall 134 a and second side wall 134 b are both adjacent to the bottom wall 126. The side walls 134 a and 134 b are adjacent to side wall fold lines 136 a and 136 b, respectively.

A first side wall flap 140 a is adjacent the first side wall 134 a. A second side wall flap 140 b is adjacent to the second side wall 134 b. The side walls 134 a and 134 b are configured to receive text. Additionally, each side wall flap 140 a and 140 b comprises a pair of locking tabs including locking tabs 144 a and 144 a′ that are at the outer edge of side wall flap 140 a and interface or are “locked” into cuts 130 a and 130 a′. On the opposite end of the blank 110, locking tabs 144 b and 144 b′ interface with cuts 130 b and 130 b′, respectively.

A front wall 146 is adjacent the bottom wall 126. The front wall 146 is bordered by front wall fold lines 148 a and 148 b. Front wall tabs 150 a and 150 b are adjacent the front wall fold lines 148 a and 148 b, respectively. Additionally, the front wall 146 is separated from the bottom wall 126 by a front wall/bottom wall fold line 152 and an edge slot 154. The front wall 146 also includes a closing slot 156 and a plurality of circular cuts 158 where each cut has a corresponding fold line 160.

A front flap 162 is configured to interface with the closing slot 156. The front flap 162 is adjacent the top wall 112 and both elements are separated by a front flap/top wall fold line 164. The front flap 162 also includes a lip 166 that is bounded by arcuate edge 168 a and 168 b. The lip 166 is received by the closing slot 156 of the front wall 146. The front flap 162 also comprises an opening 170 that is trapezoidal in shape, has rounded edges, and is bordered by the lip 166 and the arcuate edges 168 a and 168 b. Additionally, the front flap 162 comprises grooved perforations 172 a and 172 b that are adjacent to cut-outs 174 a and 174 b. In the illustrative embodiment, the cut-outs 174 a and 174 b are configured to receive glue or other such adhesive and are fixedly coupled to the front wall 146. The grooved perforations 172 a and 172 b are located between cut-outs 174 a and 174 b and the trapezoidal edge of the front flap 162 that is adjacent the opening 170. The front flap 162 also comprises front flap fold lines 176 a and 176 b that allow the lip 166 to move about the axis defined by the front flap fold lines 176 a and 176 b, so the lip 166 can be easily inserted and released from closing slot 156.

Referring to FIG. 15B there is shown an illustrative embodiment of an isometric view of an assembled box 180 without any print placed on the blank 110. The second side wall 134 b is shown. The back face of the top wall 112 and the front flap/top wall fold line 164 has been folded over at a 90° angle so that the front flap 162 is coupled to front wall 146 by inserting the lip 166 into closing slot 156.

The front flap 162 has an associated opening 170 that permits an illustrative patient to view a portion of the front wall 146. In the illustrative embodiment, the circular cuts 158 are visible through the opening 170. The front flap 162 has a rounded end that is adjacent the edge slot 154, wherein the edge slot 154 follows the fold line 152 and enables the lip 166 to easily separate from closing slot 156. In the illustrative embodiment, the cut-outs 174 a and 174 b are glued or fixedly coupled to the front wall 146. When a sealed assembled box 180 is opened, the curved perforations 172 a and 172 b define where the front flap 162 is perforated and separated from the cut-outs 174 a and 174 b that become associated with the front wall 146.

Thus, the assembled box 180 is opened when the front flap 162 is lifted and separated from the front wall 146. When the front flap 162 is separated from front wall 146, the front flap 162 may be slightly bent along front flap fold lines 176 a and 176 b.

Referring to FIG. 16A there is shown a label area on a pre-assembled blank 190 that is similar to blank 110 described in FIG. 15A. The information on label 192 is located on the front face of the blank 190 and includes information that is associated with a particular patient. The label 192 may be affixed separately as a separate label, printed on the blank 110 in the label area, or any combination thereof. The label area includes the top wall 112, and top side flaps 116 a and 116 b described in FIG. 15A.

Referring to FIG. 16B there is shown a variety of printable areas on the back face of the assembled box 200. The first printable area 202 on the front wall 146 includes printed letters 203 on the circular cuts 158 corresponding to each day of the week where M is Monday, T is Tuesday, W is Wednesday, Th is Thursday, F is Friday, Sa is Saturday, and Su is Sunday. The second printable area 204 on the back face of the top wall 112 and includes the week, the filling date, the patient name, an illustrative bar code and an interval or dosage period for consuming the medications, e.g. Morning. The third printable area 206 is disposed on the back face of second side wall 134 b and includes an illustrative 800 number.

Referring to FIG. 17, there is shown a folded box with an exposed label area or print area defined by the top wall 112 and top side flaps 116 a and 116 b as described above. The foldable box comprises a lid 210 a and a cavity configured to receive the strip or group of pouches. The illustrative lid 210 a includes the top wall 112, top side flaps 116 a and 116 b and the front flap 162.

Referring to FIG. 17 and back to FIG. 15A, the illustrative lid 210 a is adjacent to a back wall 118 (shown in FIG. 15A) that is rotatable along the top wall/back wall fold line 124 (also shown in FIG. 15A). In the illustrative embodiment, the lid 210 comprises the label 192 with a description of the medications housed by the foldable box. Additionally, the label 192 comprises a description of precautions corresponding to the medications as described in further detail below in FIG. 18A.

Referring to FIGS. 18A-18G there is shown an illustrative label. The label is an exploded view of the label 192. The label 192 may be affixed separately or the label may be printed directly on the cardboard blank 110 in the print area, or any combination thereof. The label area or print area on the illustrative assembled box 200 includes the top wall 112 and top side flaps 116 a and 116 b as described above. The illustrative label 192 is not visible when the assembled box 200 is closed. Note, the terms “label area” and “print area” are used herein interchangeably.

The illustrative label 192 comprises a plurality of printed text that may include: the patient's name 240, the interval during which the medications are taken, e.g. morning, a picture of the patient 242, patient number 244, order number 246, a list of precautions 248, a listing of the medications 250, a listing of the time interval for taking the medications 252, a prescription number 254, quantity of tablets per prescription 256, quantity of refills 258, length of prescription 260, the prescribing physician 262, the manufacturer of the tablets 264 and the lot number 266 corresponding to each tablet. Additionally, a picture 268 of each tablet is provided and the dosage concentration 270 is provided for each medication. Information about the associated generic drug 272 is also provided. Furthermore, an expiration date may also be provided for each tablet or for each prescription. Further still, information regarding the generic or trademarked name of the medication may be provided, manufacturer information, corresponding “expiration dates,” personal contact information, physician contact information, insurance information and other such information associated with the tablets in each container.

Further yet, a bar code 274 associates the medications in the foldable box with a particular patient. The bar code 274 provides a means for associating the medications in the foldable box with a particular patient. The illustrative bar code 274 is not visible when the assembled box 200 is in a closed position. Alternative means for associating the medications in the box to the patient include, by way of example but not of limitation, the patient's name, a serial number, a radio frequency identification (RFID) tag or any other such method for associating an individual with a particular item.

Referring to FIG. 19 there is shown a 30-day tablet regimen for the patient medication management system that uses the seven-day box. A patient medication management system 300 provides a compliance packaging solution. The patient medication management system 300 described herein provides a compliance package because, firstly, an action is required by the patient or caregiver that requires identifying the appropriate dosage period, e.g. morning, and selecting the appropriate pouch. Secondly, the patient opens the appropriate pouch and consumes the medication. Thirdly, the patient or caregiver records the consumption of the medication by removing or pressing the circular cuts.

The patient medication management system 300 comprises a plurality of sealed pouches that are grouped into four separate strips 302, 304, 306 and 308. The first strip 302 is a seven day strip that covers the illustrative dates of Sep. 22, 2007 through Sep. 28, 2007 and the illustrative dosing period is the “morning.” In the illustrative embodiment, the dosage period is selected from the group of dosage period intervals consisting of a morning dosage interval, a noon dosage interval, an evening dosage interval or a bedtime dosage interval.

The first strip 302 is placed into the illustrative folded box 310 that has the tablets corresponding to the first week of the 30-day regimen. The second strip 304 is a seven day strip that covers the illustrative dates of Sep. 29, 2007 through Oct. 5, 2007. The dosing period remains the same, i.e. morning. The second strip 304 is associated with folded box 312 that houses the tablets corresponding to the second week of the 30-day regimen. The third strip 306 is a seven day strip that covers the illustrative dates of Oct. 6, 2007 through Oct. 12, 2007 and, again, the dosing period is the morning. The third strip 306 is associated with folded box 314 that corresponds to the third week of the 30-day regimen.

The fourth strip 308 includes a seven day grouping of pouches 316 that covers the illustrative dates of Oct. 13, 2007 through Oct. 19, 2007; the dosing period remains the same, i.e. morning. Additionally, an empty pouch 318 is included with the fourth strip 308 that provides a reminder to place another order and an illustrative 800 number to assist in placing the refill order. Furthermore, a two day grouping of pouches 320 covers the illustrative dates of Oct. 20, 2007 through Oct. 21, 2007. The fourth strip 308 is associated with folded box 322 that houses the tablets corresponding to the fourth week of the 30-day regimen. Thus, the fourth strip 308 includes eighteen pouches that complete the 30-day regimen.

Each of the strips 302, 304, 306 and 308 are placed in the corresponding folded boxes 310, 312, 314 and 322, respectively. Each folded box or “primary container” is configured to receive at least seven pouches. Note, the terms folded box, assembled box, and “primary container” are used interchangeably throughout this patent. Thus, each primary container is configured to receive at least seven pouches that correspond to the particular dosage period and the illustrative primary container is labeled with the dosage period corresponding to the medications. Additionally, each primary container may be labeled with the patient name and dosage period as described above.

Each folded box or primary container comprises a plurality of daily indicators corresponding to a seven-day period that are disposed on the primary container. The daily indicators provide a means for recording that the medications in the pouch have been taken. An illustrative embodiment of the daily indicators has been provided above that describes a plurality of circular cuts 158 on the folded box. Each of the daily indicators is configured to indicate that the medications in the pouch have been taken, thereby providing a means for compliance packaging.

In the illustrative 30-day regimen, the sealed pouches associated with strips 302, 304, 306 and 308 include sealed pouches with a plurality of different tablets that correspond to different medications and/or vitamins. The different medications are associated with at least one prescription and each tablet includes an appropriate dosage consistent with the prescription. Each of the sealed pouches is labeled to show the medications or nutraceuticals in the pouch and labeled with a particular dosage period that includes at least one daily interval for consuming the medications in the pouch.

Referring to FIG. 20 there is shown a secondary container that receives four primary containers or assembled boxes. The secondary container 330 is configured to house the four illustrative primary containers 310, 312, 314 and 322 described above. The illustrative secondary container 330 is composed of a cardboard material. The secondary container includes a lid 332 that is rotatable about a back fold line. The illustrative lid 332 includes a plurality of side flaps.

In the illustrative embodiment, the secondary container 330 is sealed with a label 334 that affixes the lid 332 to the body of the secondary container 330. The illustrative label 334 includes the patient's name 336 and a general description that there are multiple prescription pouches 338 in the secondary container. The illustrative label 334 may also include additional information such as the dosing interval or dosing period, the prescribing physician, one or more bar codes, a patient serial number or additional information about the different medications, such as the type of prescriptions within the box, the pharmacy that filled the prescription or any other such information. To open the illustrative secondary container 330, the label 334 is simply broken by the patient or caregiver and access is provided to the 30-day regimen in primary containers 310, 312, 314, and 322.

Additionally, a medication summary sheet 340 may also be included or housed by the secondary container 330. The medication summary sheet 340 provides detailed information about the tablets in each pouch. The medication summary sheet 340 may include warnings, precautions, side effects, dosage, administration, clinical pharmacology and pictures corresponding to each medication. For example, the medication summary sheet may include summaries of the various medications being taken and summaries of the side effects. In general, the medication summary sheet provides the patient with a detailed summary of the medications being taken. The medication summary sheet 340 may also include the name of the patient, a bar code or other such identification means that ensures that the correct medication summary sheet 340 is associated with the corresponding prescription.

The illustrative secondary container 330 housing the four smaller containers may be distributed or dispensed at a retail pharmacy, by mail order or by a combination thereof. For the mail order embodiment, a mailing label is also associated with the secondary container. The mailing label enables delivery of the patient medication to a mailing address corresponding to the patient.

Referring now to FIG. 21 there is shown a plurality of different secondary containers corresponding to four different dosage periods. In the illustrative embodiment, the first dosage period is the morning dosing period corresponding to the “AM” secondary container 330. The second dosage period is the lunch-time dosing period corresponding to the “Noon” secondary container 342. The third dosage period is the dinner or evening dosage period associated with the “PM” secondary container 344. The fourth illustrative dosage period is the late night dosage period corresponding to the “Bedtime” secondary container 346. Additional dosage periods or intervals may also be necessary and the above dosage periods are illustrative and not limiting.

The secondary containers may also be combined in a tertiary container (not shown). The illustrative tertiary container may be used for shipping purposes or simply to store and transport the secondary containers.

Referring now to FIG. 22, there is shown another type of primary container configured to interface with a stackable strip of medicament cups that are associated with an individual regimen. As shown, strips of medicament cups, such as the illustrative strips of cups shown in FIGS. 5-7 and 9A-9B, are placed into primary containers after being folded into the stacked configuration.

Referring now to FIG. 23 there is shown a plurality of different secondary containers corresponding to four different dosage periods. This tertiary container 2300 is configured to hold one week's worth of medications. In this illustrative embodiment, the first dosage period is the morning dosing period corresponding to the “AM” secondary container 330. The second dosage period is the lunch-time dosing period corresponding to the “Noon” secondary container 342. The third dosage period is the dinner or evening dosage period associated with the “PM” secondary container 344. The fourth illustrative dosage period is the late night dosage period corresponding to the “Bedtime” secondary container 346. Additional dosage periods or intervals may also be necessary and the above dosage periods are illustrative and not limiting.

Alternatively, the secondary containers may be configured such that all the medications in one secondary container are associated with one particular time period for administration in the same fashion as shown in FIG. 20.

Referring to FIG. 24A there is shown an illustrative flowchart for using the patient medication management system described above. The method 2400 is initiated at block 2402 where a secondary container associated with the appropriate time interval or dosage period is selected. As described above, the illustrative dosage periods are morning, lunch, dinner and bedtime.

The patient then proceeds to block 2404 where the patient opens the secondary container and selects the appropriate primary container at block 2406. At block 2408, the primary container is opened. Subsequently, the appropriate multiple prescription pouch is selected at block 2410 and the patient may take or consume the tablets in the multiple prescription pouch.

At block 2412, the patient or caregiver then records that the pouch has been removed by pushing out the appropriate circular cut on the primary container. This recording step completes the compliance packaging process. Alternatively, the patient may take the tablets at block 2414 after pushing out the circular cut-out.

At decision diamond 2416, the patient or caregiver determines whether to place a new order. The decision may be triggered by an empty pouch marked “Reorder” as shown in FIG. 14D that reminds the user that a new order or refill order should be placed or the decision may be triggered by the patient or caregiver taking their own initiative. The order is then placed at block 2418, where an illustrative refill order is placed.

If there is no need to place another order, the primary container is closed and returned to the secondary container that is also closed. The method then proceeds to decision diamond 2420 where the patient waits for the next time interval or dosage period. When the next dosage period arrives, the method returns to block 2402 and the entire cycle is repeated. Those skilled in the art shall appreciate that various design parameters, requirements, rulings, orders and statutes may affect the precise method employed.

Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors. The compliant package contents are consumed at a predetermined interval consistent with the prescription. Some compliant packaging solutions may not record that each of the tablets is consumed. For example, an illustrative 30-day foldable box configured to receive the plurality of pouches is presented herein.

Referring to FIG. 24B there is shown an illustrative flowchart for using the patient medication management system described above. The method 2430 is initiated at block 2432 where a secondary container associated with one of the illustrative weeks, such as week 1, is selected.

The patient then proceeds to block 2434 where the patient opens the secondary container. The method then proceeds to selects the appropriate primary container associated with the appropriate time interval or dosage period at block 2436. As described above, the illustrative dosage periods are morning, lunch, dinner and bedtime At block 2438, the primary container is opened. Subsequently, the appropriate multiple prescription pouch is selected at block 2440 and the patient may take or consume the tablets in the multiple prescription pouch.

At block 2442, the patient or caregiver then records that the pouch has been removed by pushing out the appropriate circular cut on the primary container. This recording step completes the compliance packaging process. Alternatively, the patient may take the tablets at block 2444 after pushing out the circular cut-out.

At decision diamond 2446, the patient or caregiver determines whether to place a new order. The decision may be triggered by the empty pouch marked “Reorder” as shown in FIG. 14D that reminds the user that a new order or refill order should be placed or the decision may be triggered by the patient or caregiver taking their own initiative. The order is then placed at block 2448, where an illustrative refill order is placed.

If there is no need to place another order, the primary container is closed and returned to the secondary container that is also closed. The method then proceeds to decision diamond 2450 where the patient waits for the next time interval or dosage period. When the next dosage period arrives, the method returns to block 2432 and the entire cycle is repeated. Those skilled in the art shall appreciate that various design parameters, requirements, rulings, orders and statutes may affect the precise method employed.

Compliant packaging may also include a compliant package having a plurality of different tablets corresponding to one or more prescriptions from one or more medical doctors. The compliant package contents are consumed at a predetermined interval consistent with the prescription. Some compliant packaging solutions may not record that each of the tablets is consumed. For example, an illustrative 30-day foldable box configured to receive the plurality of pouches is presented herein.

Referring to FIGS. 25A-25C, there are shown isometric views of the 30-day tablet dispensing container 400. In general, the illustrative 30-day tablet dispensing container is a foldable box that includes a top wall, a front side wall, a right-side wall, a back side wall, a left-side wall and a bottom wall. The top wall has one end fixedly coupled to the foldable box and an opposite end that provides a foldable lid. The front side wall has a removable lid that is bordered by a plurality of perforations. The right-side wall abuts the front side wall and the top wall. The back side wall abuts the right-side wall and the top wall. The left-side wall abuts the top wall and is between the back side wall and the front side wall. The bottom wall abuts the front side-wall, the right-side wall, the back side, and the left-side wall. The container is formed to receive a plurality of pouches as described herein.

By way of example and not of limitation, the illustrative cardboard used to construct container 400 includes an outer smooth layer of paper and a thick interior layer. The outer smooth layer may receive printed text or images using an illustrative laser printer, ink jet printer or other such printing means. Additionally, the outer layer may also be configured to receive a label that is affixed thereto.

In the illustrative embodiment, a perforated, removable lid 404 makes up a large portion of the front side wall 406 and top wall 402 of the illustrative container 400. The lid can be partially or completely removed in order to access the medicament pouches within the container 400. In one embodiment the lid 404 may only occupy one wall such as the front side wall. In the illustrative embodiment, the lid occupies the front side wall 406 and extends to the top wall 402.

The illustrative top wall 402 has one end fixedly coupled to the foldable box and an opposite end that provides a foldable lid. A secondary label 475 is configured to seal the foldable lid on the top wall. In the illustrative embodiment, the secondary label has a bar code (shown in FIG. 18G) and includes the time interval when the tablets should be administered or taken. In the illustrative embodiment, the secondary label 475 visible on top wall 402 of the container 400 indicates the time period 470, the filling date 474, and the prescription start date 476 listed above the perforations of lid 404.

A portion of the primary label 500 is visible in FIGS. 25A-C, shown affixed to the container 400 such that it covers the lower portion of the left side wall of the container 400. The label goes on to cover the lower portion of the back side wall and right-side wall of the container 400. In the view shown in FIGS. 25A-C, the top wall 402, front wall 406 and left side wall 410 of container 400 are visible. The label includes important information related to the prescriptions and to the individual patient for whom the medications were prescribed.

The illustrative primary label 500 may include, for example, patient and medication data such as patient name and number, names of prescribing physicians, medicine(s), dosage strength(s), medicine quantity(s), color images of the medicine(s), prescription number(s), NDA number(s), warning(s), dosage period(s), administration schedule(s) and the like. The illustrative label strip is configured such that all information necessary for drug identification and administration is affixed to the container 400.

The illustrative container 400 comprises a cavity defined by the front side wall, the right-side wall, the back side wall, the left-side wall and the bottom wall, wherein the cavity is configured to receive the plurality of filled pouches that are associated with a bar code. The plurality of filled pouches includes at least 28 filled pouches, in which each pouch comprises a plurality of different tablets associated with a prescription. The barcode is associated with at least one of the pouches, wherein the barcode is associated with the prescription.

Referring to FIGS. 26A-26E there is shown an illustrative primary label 500. The primary label 500 is the large label that is affixed to the side walls. The secondary label 475 is affixed between the top wall and the back side wall. The primary label 500 is affixed to the foldable box and includes a description of the medications and the barcode associated with the prescriptions.

The illustrative bar code provides a means for associating the labels and pouches with a particular patient. By way of example and not of limitation, the means for associating the pouches may also include a radio-frequency identification (RFID) component, writing or other such associative element capable of associating the labels, pouches and particular package with a particular patient

Starting from the left side of FIG. 26A, the label includes patient and dosage period information including time period 502, patient name 504, barcode 506, patient number 508, and order number 510. Some embodiments, particularly those embodiments suitable for use in a long-term care facility, may also include a photograph (not shown) of the patient in this portion of the label with other identifying information. In other illustrative embodiments, the label may include information about a variety of different prescriptions and medications associated with each of these different prescriptions. Furthermore, the primary label may include an expiration date for each prescription.

The time period 502 refers to the particular time of day that the patient must take the tablets within the container. In this illustrative label, the time period is “Morning.” The numeral “1” next to the word “Morning” is another reference to the time period. In this case “Morning” is the first time period during which the illustrative patient must take medications.

A barcode 506 is printed on the illustrative label 500. A barcode may appear on each element of the container and its packaging including the illustrative label 500, the container 400 as shown in FIGS. 25A-25C and an illustrative strip of packets or pouches configured to be placed within container 400. The barcodes may encode important information such as time period 502, Patient Name 504, Patient Number 508 and/or Order Number 510. The barcodes are associated with one another during container assembly and filling, improving order verification by ensuring that the appropriate pouches, having been filled with medicaments associated with a particular patient 504 and time period 502, are placed in the appropriate container 400 that is associated with the particular patient 504 and time period 502. Barcodes are also used to ensure that the appropriate label 500 is affixed to the appropriate container 400 associated with a particular patient 504 and time period 502. The barcode may also be associated with a variety of different prescriptions and the corresponding expiration date for each prescription.

Referring now to the “Precautions” section of the illustrative label 500, there is shown a list of drug precautions 514 associated with the medicaments in the illustrative order. Each drug precaution for each drug found within the container is present in the Precautions section. The Precautions section may also include information on synergistic, agonist or antagonist effects that may occur among one or more medications in the order. Each precaution 514 is associated with a numeral 512A, or with another easy-to interpret symbol. Each precaution applies to at least one drug in the order, but may apply to more than one drug.

The next column of label 500 contains another set of numerals 512B that map to the numerals 512A and thus to drug precautions 514. For example, one of the drug precautions 514 instructs patients to refer to the Patient Info Booklet for additional cautions. The 512A number “6” is associated with the Patient Info Booklet precaution. In turn, the 512B number “6” is associated with several of the prescription tablets 518. Other easily interpreted symbols could be used in place of numbers, but it is essential that the first set 512A maps exactly to the second set 512B.

Referring now to FIGS. 26C and 26D, the next part of the label 500 shows drug information, including color images 516 of each drug in the order and the name 518 of each drug in the order. The numbers 512B are grouped such that each ‘cell’ containing a group of numbers 512B is associated with exactly one drug 518. The numbers 512B show which listed precautions are associated with each prescription in the order. As shown, each precaution 514 maps to exactly one number 512A, but each precaution 514 and its corresponding number 512B may apply to more than one drug in an order. That is, each number found in the set of numbers 512A may appear associated with any or all drugs 518 in the order, depending on which group of numbers 512B appears next to the drug image 516 and name 518.

For example, on the illustrative label 500, six precautions 514 are shown, each of which is in turn associated with exactly one number 512A. The first drug 518 listed on the label is “ARICEPT.” Next to the word “ARICEPT” is shown the color image of the drug 516, and on the other side the 512B numbers “1, 2, 3, & 4” are listed. This means that each precaution 514 associated with each of the 512A numbers “1”, “2”, “3”, and “4” applies to “ARICEPT.” Further, the number “4” appears in the groups of numbers 512B adjacent to three of the six illustrative drugs, and number “6” appears in the groups of numbers 512B adjacent to five of the six drugs listed, while the 512B number “5” is listed next to only one drug. This means that the precaution 514 associated with 512A number “5” applies only to one drug, while the precaution 514 associated with 512A number “6” applies to almost every drug in the order.

The “Medication/Rx#” section of FIG. 26D includes the drug images 516 and the drug name 518 mentioned above, in addition to the unit dosage 520, the drug format 521 and the prescription number 528. Thus, a variety of different prescriptions may be consolidated and integrated into the primary label 500. The prescriptions may also include different expiration dates as indicated by the dates in column 522, shown in FIG. 26E. The color images 516 show both the front and the back of each tablet. The color images allow the patient or a caregiver to identify individual medications within each pouch by using the label 500 as a key. If a patient's medication must be changed in the middle of a 30-day prescription order, this allows the patient to keep taking medications from the current 30-day period by merely discarding tablets associated with any discontinued prescriptions or recommendations after opening the packet or pouch, and consuming the remaining medications.

The next column of text, shown in FIG. 26E, displays refill information 522 including the number of refills left on the prescription for that drug, the quantity of tablets that is supplied each time the prescription is filled and the date that the prescription expired. The next column of text includes the prescribing practitioner's name 524 for each drug 518 and the last column includes manufacturer information 526 including the name of the manufacturer or other manufacturer data.

Referring to FIG. 27, there is shown a side view of the front side wall for the unopened 30-day tablet dispensing container. The front part of lid 404 is visible on the front side wall. Lid 404 is removed by the patient or a caregiver in order to access the contents of the container 400. By way of example, the front lid 404 and the space below the lid have areas that display the name of the pharmacy that provides the container 400.

Referring to FIG. 28 there is shown a side view of the back side wall of the 30-day tablet dispensing container. Part of the primary label 500 is shown affixed to the lower portion of the back side wall 426 of the container 400. Additionally, part of the secondary label 475 is also shown. The visible portion of the primary label 500 includes the medicament and nutraceutical images 516, the medicament or nutraceutical name 518, the dosage amount 520, the dosage format 521, and the drug number 528 is shown. The upper portion of the back side wall 426 of container 400 includes a portion of the secondary label 475 that also has additional printed information that includes dosage period 550, patient name 552, patient number 554, order number 556, and barcode 558.

Referring to FIGS. 29A-29B, there is shown a side view of the illustrative right-side wall of the 30-day tablet dispensing container. The visible portion of primary label 500 is affixed to the lower portion of right side wall 420. The visible label portion includes the time period 502, patient name 504, barcode 506, patient number 508, order number 510, numbers 512A associated with precautions 514 (not shown), and numbers 512B. In this illustrative embodiment, the upper portion of the right side 420 includes pharmacy name 564 and contact telephone/facsimile number 560. In this illustrative embodiment, the right side 420 also includes certain additional legal information or warnings 566 regarding the package and its contents.

During the process of assembling and filling the 30-day tablet dispensing container, bar code 558 may be printed or affixed to the back of an assembled, unfilled container before any other patient-specific information is applied. Then, as the process continues, barcode 506 from the illustrative label 500 may be compared to barcode 558 that is already present on the unfilled container before the label 500 is affixed to the container. Lastly, the barcode 564 that is found on the back of each tablet pouch may be compared with the barcode 506 disposed on the label 500 and/or the barcode 558 disposed on the back side of the container. If the barcodes are properly associated, i.e. they “match”, then the strip of packets will be placed into the associated container before sealing the container. The barcode scanning can be accomplished with hand-held devices or may be automated.

Referring to FIG. 30 there is shown a side view of the illustrative left-side wall of the 30-day tablet dispensing container. The visible portion of primary label 500 is affixed to the lower portion of left side wall 410. The label portion includes the refill information 522 including quantity 534, number of refills 536, the date that the prescription is good through 538, prescribing practitioner names 524, and manufacturer information 526. In this illustrative embodiment, the upper portion of the left side 410 includes illustrative pharmacy name 568 and contact address 562.

In FIG. 31 there is shown a top view of the top wall of the unopened 30-day tablet dispensing container. The top wall 402 includes the dosage period 470, the dosage period number 472, the date that the prescription was filled 474, and the date that marks the first day of the about 30-day period during which the enclosed medicaments should be taken 476. A bottom view of the 30-day tablet dispensing container is shown in FIG. 32 that includes folded elements and glued elements of the container that make up the bottom wall 480 when the foldable box is assembled.

Referring to FIG. 33 there is shown an illustrative front view of the opened 30-day tablet dispensing container that reveals illustrative pouches where the front lid 404 (not shown) has been removed to reveal medicament packets within. Typically, the lid is removed after the user verifies that the medications are prescribed to the person that is about to take the medication by checking the patient name. The user would then verify that the time period on the illustrative container 400 corresponds to the current time of day. If this is the first time the container has been used, the illustrative user would then remove the lid 404 from the top 402 and/or the front 406 of the illustrative container 400 to reveal the contents. Next, the user would reach into the container and remove the first packet or pouch that contains medicaments. The user would then verify that the pouch or packet has the current date before opening the pouch. While the user may also re-verify that the pouch or packet also has the correct patient name and dosage period, this step is unnecessary due to the barcode verification (described above) used during the filling process.

Once the user has verified that the pouch removed from the container is for the correct person, date, and time period, the user may then open the pouch. The user will then administer the medication to the patient (himself or someone else). The patient will take the medication and discard the empty pouch. The process will be repeated for the next dosage period, such as mid-day.

The illustrative pouch described above can be opened with only one hand, making it easier for those with limited motion to self-administer even complex medication regimens. In this way, the 30-day tablet dispensing container system described herein provides a compliance mechanism that is simple to understand and intuitive to use for patients and caregivers alike.

The illustrative 30-day tablet dispensing container offers additional benefits for those with a variety of conditions that affect speech and/or upper limb mobility, including but not limited to disorders like arthritis, effects of a stroke or early stage dementia. Many of these patients develop their conditions later in life, and these patients may dislike relying on a caregiver to provide information to physicians or to self-administer complex medication regimens. The 30-day tablet dispensing container system helps these patients address both issues. For a patient, the illustrative 30-day tablet dispensing container provides drug regimen information and facilitates communication with a physician, a nurse, a third party, a spouse, a caregiver or other such individual. The 30-day tablet dispensing container also allows the illustrative patient to maintain independence by taking charge of their own medications.

Referring to FIG. 34, there is shown an illustrative flowchart 3400 describing the overall method for packaging pharmaceutical and non-pharmaceutical tablets. At optional block 3402, if the patient is a new patient, the enrollment form is received from the new patient. Proceeding to block 3404, a prescription order is received at a server. The order may, for example, be entered into the server by a patient or physician via an interface with the server. At block 3406, an order for non-prescription tablets is received at the server. In some embodiments, the server may be associated with a front-end system such as PharmaServe. The method then proceeds to block 3408, where the prescription order is verified.

Once the patient and order information are entered into the server, each order is now associated with a particular patient's individual regimen. The prescription and non-prescription orders are grouped and treated as one order within the system. Any additional prescriptions that the patient may require in the future may be added to the patient's order when prescriptions are next filled.

Moving on to block 3410, the verified prescription order that is associated with a particular patient and corresponds to specific times for administration is forwarded to production and filled. The user interface communicates with the back-end (filling) system, allowing the prescriptions to be grouped as an order during filling.

The filling process uses automated techniques. During the filling process, the tablets that are associated with the prescription order may be loaded into compliance containers that are configured for use with the system and methods described herein.

Referring now to block 3412 of FIG. 34, the method proceeds to printing of the header label. Moving on to block 3414, the filled order is inspected. The inspection process includes verifying that the tablets to be dispensed are properly associated with the particular patient and prescription order. The inspection process also includes inspection of the filled packages to ensure that the distribution of the tablets within the containers is consistent with the patient's dosage regimen. Further, the labeling corresponding to a particular time period and specific dates for administration is associated with the pouches or cups that contain the associated tablets. The header labeling associated with the order is also inspected and verified to be of legible print quality. Inspected strips are matched with the appropriate secondary container and the corresponding integrated labeling.

Moving on to block 3416, the strips are sealed within the appropriate secondary container and all secondary containers corresponding to a complete order are placed into a shipping container.

It is to be understood that the detailed description of illustrative embodiments provided for illustrative purposes. The scope of the claims is not limited to these specific embodiments or examples. The foldable box holding a plurality of pouches, manufacturing separable pouches with a center cut blade, and patient medication management system provides patients or caregivers with the peace of mind of knowing that the right medication will be taken at the right dosage period each day. Thus, the patient medication management system and method removes the worries surrounding medication mishaps and enabling the patient to live independently longer. Various structural limitations, elements, details, and uses can differ from those just described, or be expanded on or implemented using technologies not yet commercially viable, and yet still be within the inventive concepts of the present disclosure. The scope of the invention is determined by the following claims and their legal equivalents. 

What is claimed is:
 1. A container for dispensing pharmaceutical and non-pharmaceutical tablets, comprising: a prescription tablet pouch configured to receive at least one type of prescription drug tablet; a non-prescription tablet pouch separably coupled to the prescription tablet pouch, the non-prescription tablet pouch configured to receive at least one type of non-prescription tablet; a header label separably coupled to the prescription tablet pouch, the header label comprising information indicating a time at which the contents of the prescription tablet pouch and the contents of the non-prescription tablet pouch are to be consumed.
 2. The container of claim 1 wherein the prescription tablet pouch and the non-prescription tablet pouch are labeled with information related to the contents of the pouch.
 3. The container of claim 2 wherein the information related to the contents of the pouch comprises the name of the patient, a date the tablets are to be consumed, a time of day the tablets are to be consumed, a name of the tablet contents, a prescription number, and an expiration date.
 4. The container of claim 2, wherein the colors used to mark the prescription tablet pouch are the inverse of the colors used to mark the non-prescription tablet pouch.
 5. The container of claim 1, wherein the prescription tablet pouch is marked with a symbol indicating prescription contents and the non-prescription tablet pouch is marked with a symbol indicating non-prescription contents.
 6. The container of claim 1, wherein the prescription tablet pouch and the non-prescription tablet pouch are marked with a bar code associating the contents of the pouch with a particular patient.
 7. The container of claim 1, wherein a coupling between the prescription tablet pouch and the non-prescription pouch is a center cut coupling.
 8. A strip of containers for dispensing pharmaceutical and non-pharmaceutical tablets, comprising: at least one container separably coupled to another container, each container comprising: a prescription tablet pouch configured to receive at least one type of prescription drug tablet; a non-prescription tablet pouch separably coupled to the prescription tablet pouch, the non-prescription tablet pouch configured to receive at least one type of non-prescription tablet; a header label separably coupled to the prescription tablet pouch, the header label comprising information indicating the time at which the contents of the prescription tablet pouch and the contents of the non-prescription tablet pouch are to be consumed.
 9. The strip of containers of claim 8, wherein the strip comprises one or more containers corresponding to each day of a week.
 10. The strip of containers of claim 8, wherein the strip comprises a secondary label comprising information corresponding to the strip of containers.
 11. The secondary label of claim 10, wherein the information corresponding to the strip of containers comprises an image of the patient.
 12. The secondary label of claim 10, wherein the information corresponding to the strip of containers comprises a bar code associating the contents of the strip with a particular patient.
 13. The container of claim 8 wherein the prescription tablet pouch and the non-prescription tablet pouch are labeled with information related to the contents of the pouch.
 14. The container of claim 13 wherein the information related to the contents of the pouch comprises the name of the patient, a date the tablets are to be consumed, a time of day the tablets are to be consumed, a name of the tablet contents, a prescription number, and an expiration date.
 15. A method for packaging pharmaceutical and non-pharmaceutical tablets, the method comprising: receiving at a server an order for tablets comprising an order for at least one type of prescription tablet and an order for at least one type of non-prescription tablet; generating with the server instructions for filling a plurality of prescription tablet pouches and non-prescription tablet pouches; filling by automated means a plurality of prescription tablet pouches with the at least one type of prescription tablet; filling by automated means a plurality of nonprescription tablet pouches with the at least one type of non-prescription tablet; printing by automated means a plurality of labels comprising information indicating the time at which the contents of the prescription tablet pouch and non-prescription tablet pouch associated with each label are to be consumed.
 16. The method of claim 15, wherein the plurality of labels are further printed with information related to the contents of the pouch.
 17. The method of claim 16, wherein the information related to the contents of the pouch comprises the name of the patient, a date the tablets are to be consumed, a time of day the tablets are to be consumed, a name of the tablet pouch contents, a prescription number and an expiration date.
 18. The method of claim 16, wherein the colors used to mark the prescription tablet pouch are the inverse of the colors used to mark the non-prescription tablet pouch.
 19. The method of claim 15, further comprising marking the prescription tablet pouch by automated means with a symbol indicating prescription contents and marking the non-prescription tablet pouch by automated means with a symbol indicating non-prescription contents.
 20. The method of claim 15, further comprising marking the prescription tablet pouch and the non-prescription tablet pouch with a bar code associating the contents of the pouch with a particular patient. 